MAUDE Adverse Event Report: 3M HEALTH CARE 3M MULTIPORE DRY SURGICAL TAPE; 3M MULTIPORE DRY TAPE

Model Number	N/A
Medical Device Problem Codes	Stretched (1601); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier, sex, ethnicity, race: information was not provided by reporter.Sample has not yet been returned for evaluation.Lot number was not provided.The tape was used to secure an endotracheal tube (brand unspecified) while the patient was at the neonatal station in an incubator at 30.5 degrees c and 45% humidity.The tape was used for approximately 24 hours prior to observation of the issue, and was reported to have stretched and lost adherence; adhesive was observed on the skin.
Event or Problem Description
Received from (b)(6): customer reported 3m¿ multipore¿ dry surgical tape that was used to secure an endotracheal tube for a (b)(6) old infant who was in an incubator in a neonatal station slipped, stretched and lost adherence approximately 24 hours after application.Adhesive was observed on the patient's skin.The tube was dislocated and re-taped several times before it was re-affixed with a non-3m brand tape.No extubation or patient injury occurred.
Additional Manufacturer Narrative
Product samples were received from the customer.The samples were tested and met specifications for adhesion.

• Brand Name: 3M MULTIPORE DRY SURGICAL TAPE
• Common Device Name: 3M MULTIPORE DRY TAPE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; mn
• MDR Report Key: 9825410
• Report Number: 2110898-2020-00016
• Device Sequence Number: 16501799
• Product Code: KGX
• UDI-Device Identifier: 34549395423560
• UDI-Public: 34549395423560
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 3730-0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2020
• Supplement Date Received by Manufacturer: 02/14/2020
• Initial Report FDA Received Date: 03/12/2020
• Supplement Report FDA Received Date: 04/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 3 WK
• Patient Weight: 1